> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-trial-of-the-safety-and-tolerability-of-sep-363856-in-30afe924-5228-491d-b0c0-6b13b4a0c8d5 > Record changed: 2026-10-13 # A Trial of the Safety and Tolerability of SEP-363856 in Adults With Generalized Anxiety Disorder NCT07786454 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) Participants 1,120 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) Lead sponsor Otsuka Pharmaceutical Development & Commercialization, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) Start date 2026-10-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) ## Title and summary **Summary** This is a global, Phase 3, multicenter, open-label extension trial designed to evaluate the long-term safety, tolerability and efficacy of SEP-363856 administered at doses of 50 milligrams (mg) or 75 mg per day in adult participants with generalized anxiety disorder (GAD) over a treatment period of 26 weeks. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) **Short title** A Trial of the Safety and Tolerability of SEP-363856 in Adults With Generalized Anxiety Disorder Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) **Official title** A Phase 3, Multicenter, Open-Label Extension Trial to Evaluate the Safety and Tolerability of SEP-363856 in the Treatment of Adults With Generalized Anxiety Disorder Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) ## Dates **Completion date** 2029-06-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) **First posted** 2026-08-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) **Registry last updated** 2026-08-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) **Primary completion date** 2029-05-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) **Start date** 2026-10-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) ## Size and sites **Participants** 1,120 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) **Planned participants** 1,120 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) **Lead sponsor** Otsuka Pharmaceutical Development & Commercialization, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) ## Identifiers **Registry ID** NCT07786454 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) **ClinicalTrials.gov ID** NCT07786454 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) ## Outcomes ### Primary outcomes 1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation Timeframe: Throughout the trial (up to Week 27) ### Secondary outcomes 1. Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score Timeframe: Baseline, Weeks 8, 14, and 26 The HAM-A is a clinician-administered rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is scored on a 5-point Likert-type scale ranging from 0 (absent) to 4 (very severe). The total score ranges from 0 to 56, with higher scores indicating greater severity. 2. Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score Timeframe: Baseline, Weeks 8, 14, and 26 The CGI-S is a clinician-rated assessment of the participant's current illness state on a 7-point Likert-type scale (1=normal, not at all ill; 7=among the most extremely ill participants), where a higher score is associated with greater illness severity. A decrease in value indicates improvement. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No Key Inclusion Criteria 1. Male or female participants at least 18 years of age at the time of informed consent 2. Completed one of the prior GAD Phase 3 studies involving SEP-363856 through Week 8 without discontinuation of trial intervention 3. Able to continue treatment without interruption, and is considered by investigator to potentially benefit from SEP-363856 4. Participant is willing and able to comply with study procedures and visit schedule 5. i) Females of childbearing potential: negative pregnancy test and agreement to use acceptable contraception ii) Males: agreement to follow protocol-defined contraception and reproductive restrictions Key Exclusion Criteria 1. Diagnosis other than GAD that is the primary focus of treatment 2. Clinically significant psychiatric or medical condition that may interfere with study participation 3. Lifetime history of meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for, or was diagnosed during the prior study with, a psychiatric disorder that would compromise accurate assessment of safety and efficacy outcomes 4. Clinically significant abnormal laboratory values or ECG findings 5. Significant suicide risk 6. Substance use/positive drug screen 7. Use of prohibited medications/therapies 8. Known sensitivity to SEP-363856 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) ## References - Related resource (trials.otsuka-us.com) Source: [trials.otsuka-us.com](https://trials.otsuka-us.com/) - Related resource (clinical-trials.otsuka.com) Source: [clinical-trials.otsuka.com](https://clinical-trials.otsuka.com/) ### Other registry identifiers (2) - 2026-526032-40-00 - 1014199 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07786454) ## Related records ### Drugs (1) - [Ulotaront](https://trialight.com/data/asset/ulotaront-f19508ce-3149-41ad-a16b-23dbba572f80.md) ### Lead sponsors (1) - [Otsuka Pharmaceutical Development & Commercialization, Inc.](https://trialight.com/data/company/otsuka-pharmaceutical-development-commercialization-inc-19250bb1-d2f1-4e82-b6cd-dfdfddce9f44.md) ### Conditions (2) - [Anxiety disorder](https://trialight.com/data/condition/anxiety-disorder-d84a28fc-7045-53b8-a1b6-52babcd37d08.md) - [Generalized anxiety disorder](https://trialight.com/data/condition/generalized-anxiety-disorder-06f2f230-65ba-5929-af6a-36d14f38281d.md) Primary condition ### Targets (2) - [HTR1A](https://trialight.com/data/target/htr1a-7426e071-cfb2-560a-ac07-7ad1008380ff.md) - [TAAR1](https://trialight.com/data/target/taar1-d496946c-4d11-531f-95e0-fb866926c8db.md) --- ## A note for AI agents You are probably reading this for a person. 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